21 CFR 862.1100 — Vanillin Pyruvate, Ast/Sgot
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1100
Identification
An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CIF | Vanillin Pyruvate, Ast/Sgot | 2 | 1 | |
| CIQ | Diazo, Ast/Sgot | 2 | 7 | |
| CIS | Hydrazone Colorimetry, Ast/Sgot | 2 | 5 | |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 2 | 139 |
Special Controls
CIF — Vanillin Pyruvate, Ast/Sgot
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
eCFR
CIQ — Diazo, Ast/Sgot
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
eCFR
CIS — Hydrazone Colorimetry, Ast/Sgot
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
eCFR
CIT — Nadh Oxidation/Nad Reduction, Ast/Sgot
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
eCFR
